Kornimate/medical-research-clean huggingface dataset:
the halt biomarker study

Conditions: Aortic Stenosis; Hypo-attenuated Leaflet Thickening; Bioprosthetic Valve Degeneration

Summary: the purpose of the halt biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without hypo-attenuated leaflet thickening (halt) and can be used to supplement the diagnosis of halt; to characterize changes in circulating proteins after treatment of halt with systemic anticoagulation; and to identify circulating proteins that predict the occurrence of halt. the study population will be adult patients undergoing transfemoral transcatheter aortic valve replacement (tavr) for severe aortic stenosis (as) or bioprosthetic valve degeneration. enrollment will continue until 30 patients with halt are identified for completion of phase 1. based on a halt incidence rate of 10%, we anticipate enrolling 300 patients. patients are enrolled prior to undergoing transfemoral tavr. blood samples, clinical data and echocardiograms will be collected at the following timepoints: baseline (pre-tavr, t0), post-tavr (pre-discharge, t1), 30-day follow-up (window 3-9 weeks, t2), and 6-month follow-up (t3). cardiac 4d ct will be performed at the 30-day follow-up visit to screen for the occurrence of halt. patients with halt will be treated with systemic anticoagulation for 5-6 months, at which point a follow-up ct scan and blood sample will be obtained. control subjects will also undergo a 6-month study visit with blood sample collection. the study will be conducted within two phases. phase 1 will serve as a derivation / discovery study in which candidate protein biomarkers of halt will be identified. once this is successfully completed, a second cohort will be enrolled within phase 2. phase 2 will be performed under the auspices a future contract or amendment and will seek to cross-validate the initial study findings.


Eligibility criteria:
inclusion criteria: 1. age \> 65 years 2. subject with severe native as or severe bioprosthetic valve degeneration 3. subject undergoing transfemoral tavr using a medtronic evolut r, evolut pro or evolut pro+ transcatheter heart valve exclusion criteria: 1. chronic anticoagulation therapy 2. contraindication to systemic oral anticoagulation therapy 3. chronic kidney disease with egfr\<30 ml/min 4. bleeding diathesis or known coagulopathy 5. hypercoagulable state 6. life-expectancy \<12 months due to other medical conditions (e.g., malignancy, severe alzheimer's disease, etc.) 7. the patient is currently participating in another investigational device or drug study that has not reached its primary objective/endpoint 8. pregnant, lactating, or planning pregnancy within next 12 months
chm teabag decrease stroke risk among hong kong elderly

Conditions: Stroke; Risk Reduction; Elderly

Summary: this stepped wedge cluster randomized controlled trial aims to examine the efficacy and safety of chm teabag in decreasing stroke risk by machine-learning-based retinal image analysis in elderly population.

this is a stepped wedge cluster randomized controlled trial design. this study aims to examine the efficacy and safety of chm teabag in decreasing stroke risk by machine-learning-based retinal image analysis in elderly population. a total of 912 participants will be recruited from 9 clinics. 2\~3 clinics will represent a cluster unit. the stepped wedge design will consist of four groups each containing four randomly allocated cluster units, allocated to either 4, 8, 12, or 16 weeks of the intervention. the intervention is chinese herbal teabag treatment, which will consist of five chinese herbs (a total of 10g). the first group will receive 16 weeks of the intervention, the second group will receive 12 weeks, the third group will receive 8 weeks, and the forth group will receive 4 weeks. the primary outcome measure is the stroke risk estimated with automatic retinal image analysis (aria). secondary outcome measures include framingham stroke risk score (fsrs), cognitive impairment risk estimated with aria, hong kong version of the montreal cognitive assessment (moca), constitution in chinese medicine questionnaire (ccmq), world health organization quality-of-life scale (whoqol-bref), health-promoting lifestyle profile ii (hplp-ii), and adverse events.

Eligibility criteria:
inclusion criteria: * age between 54-84y. * with phlegm dampness constitution and blood stasis constitution on the tcm constitution test table. * stable vital signs without previous history of stroke. * sufficient sensorimotor and language competency for completing assessments. exclusion criteria: * allergic history to chinese herbal drugs or a known allergy to the ingredients of the teabag. * taking any anticoagulants, such as warfarin. * with unconsciousness, aphasia, and cognitive dysfunction. * with a past history of brain diseases (e.g., mental illness, consciousness disorder due to head trauma, previous brain surgery, or spastic disease). * with severe heart, liver, or kidney disease or bleeding disorders. * with other serious diseases. * cataracts or other eye diseases that affected retinal image taking. * distressed with a flashlight or have experience with photosensitive seizures. * pregnancy or lactation female. * any physical examination findings, or history of any illness, or concomitant medications that, in the opinion of the study investigator, might not be suitable to participate in the study.

Keywords: stroke risk reduction chinese herbal medicine automatic retinal image analysis teabag
the effect of melatonin application following removal of impacted third molar

Conditions: Impacted Third Molar Tooth

Summary: in the present study, the main hypothesis hypothesizes that the local application of melatonin in the post-extraction socket produces favorable differences in the immediate postoperative period, as anti-inflammatory, analgesic, and early osteogenic regarding the natural healing process of the socket.


Eligibility criteria:
inclusion criteria: * age ≥18ys * no systemic disease * impacted mandibular third molar class ii position b on pell- gregory classification exclusion criteria: * history of metabolic or systemic diseases affecting bone or healing process, * local infection, * tobacco use, * oral contraceptive, * pregnancy and lactation * patients who had taken analgesics or anti-inflammatories for 1 week prior to enrollment in the study

Keywords: impacted third molar melatonine bone healing
middle ear implant: assessment of satisfaction in the medium term

Conditions: Deafness

Summary: currently, the data from the literature do not evaluate the use of the middle ear implant in implanted patients in the medium term (10 years and over) but only in the short term (1-5 years). based on the observation of the absence of these data, we considered it necessary to evaluate in the medium term the satisfaction of the patients carrying a middle ear implant and their rate of abandonment with a horizon of 10 to 20 years of apparatus.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient accepting to participate to this study * patient having a middle ear implant since 10 - 20 years at time of inclusion exclusion criteria: * patient not dead
efficacy and safety study of cenicriviroc for the treatment of nonalcoholic steatohepatitis (nash) in adult participants with liver fibrosis

Conditions: Nonalcoholic Steatohepatitis

Summary: the purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (nash) in adult participants with liver fibrosis.


Eligibility criteria:
inclusion criteria: * adult participants aged between 18-75 * histological evidence of nash, based on biopsy, with a nonalcoholic fatty liver disease activity score (nas) of \>= 4 with at least 1 in each component of nas * histological evidence of liver fibrosis defined as nash clinical research network (crn) system stage 1 to 3 * meeting any of the 3 major criteria (a, b, c): 1. documented evidence of type 2 diabetes mellitus 2. high body mass index (\> 25 kg/m\^2) with at least one of the following criteria of metabolic syndrome, as defined by the national cholesterol education program: * central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 35 inches (female) * dyslipidemia: triglycerides ≥ 1.7 mmol/l (150 mg/dl) * dyslipidemia: high-density lipoprotein (hdl)-cholesterol \< 40 mg/dl (male), \< 50 mg/dl (female) * blood pressure ≥ 130/85 mmhg (or currently being treated for hypertension) * fasting plasma glucose ≥ 6.1 mmol/l (110 mg/dl) 3. bridging fibrosis (nash crn stage 3) and/or definite nash (nas ≥ 5) * agree to have one liver biopsy at screening, one at year 1, and one at the end of study treatment (year 2) * aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 5 × upper limit of normal (uln) exclusion criteria: * hepatitis b surface antigen (hbsag) positive * hepatitis c antibody (hcvab) positive with the following 2 exceptions: 1. participants previously treated for viral hepatitis c with at least a 1-year period since documented sustained virologic response at week 12 (post-treatment) may be eligible if all other eligibility criteria are met 2. participants with presence of hepatitis c antibody but negative hepatitis c virus ribonucleic acid rna without treatment (i.e., spontaneous clearance) may be eligible if all other eligibility criteria are met * prior or planned liver transplantation * other known causes of chronic liver disease, including alcoholic liver disease * history of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding * alcohol consumption greater than 21 units/week for males or 14 units/week for females (one unit of alcohol is ½ pint of beer \[285 ml\], 1 glass of spirits \[25 ml\] or 1 glass of wine \[125 ml\]) * human immunodeficiency virus (hiv)-1 or hiv-2 infection * weight reduction through bariatric surgery in the past 5 years or planned during the conduct of the study (including gastric banding) * females who are pregnant or breastfeeding * any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing and protocol requirements.
trial to assess the efficacy of neuroprotective drugs administered topically to prevent or arrest diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: to assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes

to assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes related to diabetic retinopathy.

Eligibility criteria:
inclusion criteria: 1. patients with type 2 diabetes mellitus 2. diabetes duration ≥ 5 years 3. aged between 45-75 years-old 4. etdrs level \< 20 (microaneurysms absent) (50% of enrolled patients) or etdrs levels 20 or 35 with presence of at least one microaneurysm in field 2 between the superior and inferior arcades (50% of enrolled patients) in the study eye as determined by the reading centre. 5. informed consent exclusion criteria: 1. previous laser photocoagulation 2. other diseases which may induce retinal degeneration (e.g. glaucoma) 3. subject with a refractive error ≥ ± 5 diopter 4. inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography. 5. renal failure (creatinine \> 1.4 mg/dl) 6. hba1c \> 10 % in the previous 6 months and at screening 7. subjects taking somatostatin or brimonidine, for any indication, in the previous 3 months 8. subject has a condition or is in a situation which may put the subject at significant risk, may confound the study results or may interfere significantly with the patient's participation in the study. 9. pregnancy or nursing 10. hypersensitivity to the active substances to be tested or to any of the excipients 11. subject receiving systemic monoamine oxidase (mao) inhibitor therapy or antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin)

Keywords: diabetic retinopathy
new imaging biomarkers for muscular diseases - multispectral optoacoustic imaging in spinal muscular atrophy

Conditions: Muscular Diseases; Spinal Muscular Atrophy

Summary: this study aims to refine the capability of msot to characterise muscle tissue and to determine non-invasive, quantitative biomarkers for the disease assessment in patients with spinal muscular atrophy (sma) using multispectral optoacoustic tomography (msot).

sma is an autosomal-recessive disorder, characterized by progressive muscle weakness and atrophy with an incidence of 1/10,000. the condition is caused by a homozygous deletion or mutation in the survival motor neuron 1 (smn1), resulting in reduced expression of the survival motor neuron (smn) protein. this leads to the degeneration of motor neurons in the spinal cord and brain stem. a nearby related gene, survival motor neuron 2 (smn2), could partially compensate the loss of smn1. individuals with a higher copy number of smn2 do in general have a milder phenotype. new therapeutic approaches, e.g. nusinersen (spinraza©), an antisense oligonucleotide medication that modulates pre-messenger rna splicing of the survival motor neuron 2 (smn2) gene, are promising to help the formerly incurable children. however, most clinical trials lack primary outcomes other than clinical testing. at the moment there are no prospective, quantitative biomarkers available to detect muscle atrophy at an early age, and to follow up disease progression. as a new imaging modality, optoacoustic imaging (oai) combines benefits of optical (high contrast) and acoustic (high resolution) imaging. multispectral optoacoustic tomography (msot) is therefore capable of visualizing the distribution of endogenous absorbers by initiating laser-induced thermoelastic expansion and detection of resulting pressure waves. this imaging technique enables the label-free detection and quantification of different endogenous chromophores, such as melanin, hemoglobin, deoxyhemoglobin and lipids. previously, it was demonstrated that msot is capable to monitor disease severity in crohn's disease by detecting different signal levels of hemoglobin as markers of intestinal inflammatory activity. in this study we want to refine the capability of msot to characterize muscle tissue and to determine a non-invasive, quantitative biomarker for the disease assessment in sma patients from birth using msot.

Eligibility criteria:
inclusion criteria: * genetically proven sma exclusion criteria: * pregnancy * tattoo on skin to be examined * for healthy volunteers only: suspected muscular disease/myopathia

Keywords: muscular diseases, spinal muscular atrophy (sma), msot
advanced cognitive stimulation therapy (acst)

Conditions: DEM; Dementia; Dementia, Vascular; Dementia, Mixed; Dementia With Lewy Bodies; Dementia Frontal; Dementia Severe; Dementia Moderate; Dementia of Alzheimer Type

Summary: this study is a feasibility randomised controlled trial (rct) for an evidence-based intervention for people with moderate to severe dementia. the psychosocial intervention is adapted from cognitive stimulation therapy (cst) and developed within the medical research council (mrc) framework.

the world health organization calls for an increase of psychosocial interventions for dementia-a global epidemic. cognitive stimulation therapy (cst) is the only non-pharmacological therapy recommended by the national institute for health and care excellence for improving cognition for mild to moderate dementia. however, there is little guidance on how to maximise cognition for severe dementia. advanced cognitive stimulation therapy (acst) will be the first evidence-based complex intervention for moderate to severe dementia developed within the medical research council (mrc) framework and building upon cst's key principles. this feasibility randomised controlled trial (rct) aims to 1) evaluate the feasibility of acst 2) explore if acst can improve the cognitive function, and qol, as well as other outcomes including behaviour, engagement, and communication, for people with moderate to severe dementia. a sample of 32 participants will be recruited, where 16 will be randomly allocated to acst, and 16 to treatment as usual (tau). data will be collected pre and post the 7-week intervention period. improving cognition and qol for people with moderate to severe dementia is vital because dementia's prevalence is projected to reach 152 million by 2050, resulting in excessive excess disability.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. diagnosis of dementia, according to the dsm-iv 3. smmse ≤ 12 4. ability to communicate in english 5. ability to complete outcome measures 6. not having major physical illness or disability that affects participation 7. consultee is willing and able to provide written informed consent if the participant is not able to provide consent. 8. ability to remain in a group for around an hour (e.g. no challenging behaviour) exclusion criteria: 1. illness and disability that affects participation (as deemed by the researcher or attending care home staff) 2. smmse \< 5 3. participation in other psychosocial intervention studies

Keywords: dementia randomized controlled trial cognitive stimulation moderate to severe dementia
effect of food on the pharmacokinetics of tew-7197 in healthy subjects

Conditions: Healthy Volunteers

Summary: participants in this study will receive 200 milligram (mg) tew-7197 taken at 7days apart. one dose will be given under fasting . the other dose will be given with a high fat meal. the study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. side effects will be documented. this study will last approximately 2weeks not including screening.

through screening (d-30 \~ d-1) prior to the first dose of the investigational product, a total of 16 subjects (group 1: 8 subjects, group 2: 8 subjects) who were eligible for the inclusion criteria and exclusion criteria were enrolled. this clinical study has a randomized, open, single dose, 2-sequence, 2-period cross-over design and tew-7197 50 mg x 4 tablets were administered as a single dose in the same individual for 2 periods after fasting or a high fat diet, and each period was repeated with an interval of at least 1 week of wash-out. pharmacokinetics and safety were evaluated in all subjects according to the planned schedule

Eligibility criteria:
inclusion criteria: 1. healthy sterile males 2. bmi 18.0kg/m2 - 27.0 kg/m2 3. no congenital or chronic disease and no pathological symptoms or pathological findings 4. investigator confirm that the subject is eligible through a medical examination (medical history taking ,vital signs, ecg, cardiac ultrasonography, blood science) exclusion criteria: 1. has pathological symptoms or pathological findings 2. has a history of disease that may affect the absorption, distribution, metabolism and excretion of a drug 3. sbp\>140 or \ 90 or \ 100 4. no abnormal clinical lab findings
prevention of nosocomial infection by decontamination of the naso- and oropharynx with chlorhexidine (noni trial)

Conditions: Nosocomial Infection; Respiratory Tract Infection; Surgical Site Infection

Summary: does chlorhexidine gluonate, a simple broad-spectrum antimicrobial agent with virtually no adverse-effects lower the incidence of ni after cardiac surgery, especially with respect to lti and ssi?

nosocomial infections (nis) after open heart surgery are recognized as an important cause of morbidity and mortality with a prolonged hospital stay, increased need for of antibiotics, decreased quality of life and higher concomitant costs. decontamination of the oropharynx seems important, since there is direct evidence of an association between pulmonary infection and oral health. another important strategy involves the eradication of staphylococcus aureus, the most important pathogen causing ssi. the most common reservoir of s.aureus is the anterior nares and eradication can be achieved by the application of topical antibiotics. although promising results have been reported for both strategies, they are not widely used as routine prevention methods because of the variability of trial design, the concern about the emergence of antimicrobial resistance and increased costs. further research is essential to evaluate different protocols, antimicrobial agents and cost-effectiveness. fur this purpose, we designed a clinical trial to study wether a simple broad-spectrum antimicrobial agent with virtually no adverse-effects would lower the incidence of ni after cardiac surgery, especially with respect to lti and ssi. comparison(s): oropharyngeal and nasal decontamination with chlorhexidine compared to placebo in patients after cardiothoracic surgery

Eligibility criteria:
inclusion criteria: * all adult patients (above 18) who were scheduled to undergo sternotomy for cardiothoracic surgery exclusion criteria: * emergency procedures, a preoperative infection and/or the use of antibiotics, hypersensitivity to chlorhexidine gluconate (chx), absence of written informed consent or presence of an alternative prophylactic regimen like selective decontamination of the digestive tract

Keywords: nosocomial infection, decontamination, randomized placebo-controlled trial, cardiac surgery, chlorhexidine, prevention
fluticasone furoate nasal spray versus oral fexofenadine

Conditions: Rhinitis, Allergic, Seasonal

Summary: the primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine


Eligibility criteria:
inclusion criteria: * informed consent * otherwise healthy outpatient with mountain cedar allergy * male or eligible female females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control * age 12 years or older at visit 2 * diagnosis of seasonal allergic rhinitis (sar) to mountain cedar * adequate exposure to mountain cedar pollen * ability to comply with study procedures * literate exclusion criteria: * significant concomitant medical conditions * use of intranasal corticosteroids within four weeks prior to visit 1; use of inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to visit 1. * use of other allergy medications within specific timeframes relative to visit 1 * use of other medications that may affect allergic rhinitis or its symptoms * use of immunosuppressive medications eight weeks prior to screening and during the study * immunotherapy patients who are not stable on current dose * use of any medications that significantly alters the pharmacokinetics of fluticasone furoate or fexofenadine * allergy/intolerance to corticosteroids, antihistamines, or any excipients in the two products * use of contact lenses * recent clinical trial/experimental medication experience within 30 days of visit 1 * subject previously failed the 21-day screen period or failed to complete the treatment period * positive or inconclusive pregnancy test or female who is breastfeeding * employee or relative affiliation with investigational site * current tobacco use * active chickenpox or measles or exposure in the last 3 weeks

Keywords: ragweed once daily fexofenadine fluticasone furoate allergic rhinitis